Kornimate/medical-research-clean huggingface dataset:
impact of duotherm on acute opioid use and low back pain

Conditions: Opioid Use; Low Back Pain

Summary: evaluate the change in opioid use in patients with moderate to severe low back pain when dispensed a multimodal duotherm mechanical stimulation (m-stim) unit compared to tens transcutaneous electrical nerve stimulation.

160 patients with acute or exacerbations of chronic low back pain (lbp) presenting for chiropractic and rehabilitation care will be stratified by opioid use status (naive or prior use for lbp) and randomized to one of two conditions: an m-stim pain relief belt device incorporating 8 patterns of vibration motors (and optional heat, cold, and pressure) delivered through a sculpted metal plate; or a 4-lead tens unit with 8 channels of stimulation and adjustable intensity. patients will be prompted by a qualtrics text link to a secure data recording site collecting opioid brand, dose, pill number, and source, and pain data.

Eligibility criteria:
inclusion criteria: * male or female, aged 18-90 presenting for treatment of acute low back pain or acute exacerbation of chronic lbp; pain duration \ =3 months; self-report nrs measures \>=4, capacity to understand all relevant risks and potential benefits of the study (informed consent); willingness to communicate information on opioid use including prescription formulation, pill #, dose, and source. exclusion criteria: * opioid prescription in the past month; radicular pain likely reflecting a surgical or mechanical problem; bmi greater than 50 (device won't fit); sensitivity to cold or vibration (e.g raynaud's or sickle cell disease); diabetic neuropathy rendering a patient unable to determine if the device is too hot; new neurologic deficits, skin lesions over the low back area; a contraindication to any medication for pain management that would impact analgesic use record; inability to apply duotherm or tens device; pacemaker that would render patients unable to use the tens device.

Keywords: pain analgesia medical device opioid
study of safety and dosing effect on smn levels of valproic acid (vpa) in patients with spinal muscular atrophy

Conditions: Spinal Muscular Atrophy

Summary: this is an open label phase i/ii clinical trial to assess safety, tolerability and potential effect on smn mrna and protein in vivo of a compound in which preliminary evidence supports a potential effect on smn levels in vitro.

this is an open label phase i/ii trial of valproic acid in 40 sma subjects \> 2 years of age with severe, intermediate, and mild phenotypes. primary outcome measures includes laboratory and physical examination assessments to monitor effects on liver, hematologic, metabolic and nutritional status. secondary outcomes includes measures of gross motor function; electrophysiologic measures of denervation; dexa estimates of body composition, bone mineral density and content; measures of pulmonary function; and quantitative smn mrna and protein levels in blood cells. subjects will need 2-3 baseline visits over a 3 -6 month period prior to enrollment. follow-up visits will be scheduled at 3, 6 and 12 months on treatment.

Eligibility criteria:
inclusion criteria: * patients must have a diagnosis of sma, confirmed by genetic testing * only patients 2 years of age and older at enrollment will be eligible exclusion criteria: * patients taking any medications with known hepatotoxicity, congenital metabolic disorders or on multiple anticonvulsant medications * patients taking medications which may interact with vpa * patients on ventilatory support for more than 16 hours per day * patients currently enrolled in other treatment trials

Keywords: spinal muscular atrophy (sma) valproic acid
effect of a high-fat meal on the pharmacokinetics of shr3824 and mass balance study in healthy subjects

Conditions: Type 2 Diabetes

Summary: this open-label, randomized, two-period, two-treatment (single doses of 10 mg shr3824 fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of shr3824 and mass balance study in 12 healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy. * bmi 18-25 kg/m2. exclusion criteria: * history of clinically significant illness. * history of alcohol or drug abuse.

Keywords: shr3824 food effect mass balance phase i
foot pressure mapping and tendon length after nonoperative treatment of acute achilles tendon rupture

Conditions: Achilles Tendon Rupture

Summary: using a population of patients from another study, who was originally randomized to 2 different types of nonoperative treatment after an acute achilles tendon rupture, the length of the achilles tendon is examined using ultrasound, and foot pressure mapping is performed, 4-5 years after the injury.

a total of 56 patients from an earlier study (see reference) on achilles tendon rupture using nonoperative treatment with or without early weight bearing was invited for an additional follow up, where we examine the length of the achilles tendon using ultrasound, as well as functional influence of the injury, using foot pressure mapping (fpm) during barefoot gait. additionally the mobility of the ankle is measured with the achilles tendon resting angle (atra) as well as passive plantar- and dorsiflexion. strength is measured using heel raise work (height of lift, number of lifts and the total work), and supplemented with calf circumference.

Eligibility criteria:
inclusion criteria: * suffered acute achilles tendon rupture from april 2011 to march 2012, and then referred to copenhagen university hospital hvidovre. * participated and completed the original study. * the patient must be able to speak and understand danish, as well as be capable to give informed consent to participating. exclusion criteria: * terminal disease or serious illnesses with an asa score of 3 or above. * any injury significantly influencing gate and function of the lower extremities other than re-rupture of the achilles tendon.

Keywords: achilles tendon rupture conservative treatment early weight bearing achilles tendon length ultrasound foot pressure mapping atra heel raise work
the effect of nebivolol in hypertensive patients with coronary artery disease

Conditions: Hypertension; Coronary Artery Disease

Summary: this study is being done to see if the blood pressure lowering effect of an approved drug nebivolol is comparable to that of another approved drug carvedilol for the treatment of hypertension in patients who have coronary artery disease.


Eligibility criteria:
inclusion criteria: * male or female ambulatory outpatients 18 to 85 of age at screening * coronary artery disease as defined by: status post myocardial infarction (heart attack) greater than 14 days post event with no upper time limit (and followed by stress testing with additional imaging (echocardiographic or nuclear) within the 12 months prior to enrollment) and/or angiographic evidence of one or more major coronary arteries narrowing of greater than 50% and/or a history of percutaneous or surgical coronary revascularization greater than 4 months after that procedure at the time of enrollment. * qualifying blood pressure criteria for study entry and for randomization * willing to adhere to exercise stress (treadmill) tests exclusion criteria: * unstable angina within 7 days of screening * potential coronary surgical/intervention within the next 6 months * have any form of secondary hypertension * have a history of hypersensitivity to nebivolol, metoprolol, carvedilol, or any beta blocker

Keywords: carvedilol coreg (tm) hypertension blood pressure coronary artery disease nebivolol bystolic (tm)
degarelix neo-adjuvant radical prostatectomy trial

Conditions: Prostate Cancer

Summary: to assess the effect of neo-adjuvant gnrh antagonist, degarelix, versus lhrh agonist on intratumoral levels of androgens.


Eligibility criteria:
inclusion criteria: * men \>18 and =\< 75 years of age * willing and able to provide informed consent, either alone or with the aid of a translator * histologically confirmed prostate cancer as determined by transrectal ultrasound (trus) guided prostate biopsy performed within 6 months of study enrolment * gleason score \>= 7and/or prostate cancer that is clinical stage t2 disease. * candidates for open radical prostatectomy considered surgically resectable by urologic evaluation * normal organ and marrow function as defined by the following criteria: * eastern cooperative oncology group (ecog) performance status of 0 to 1 exclusion criteria: * previous or current use of hormonal management of prostate cancer (surgical castration or other hormonal manipulation, including gnrh receptor agonists, gnrh receptor antagonists, anti-androgens, estrogens, megestrol acetate, and ketoconazole) * history of receiving radiation to the pelvic area. * previously received therapy with 5-alpha reductase inhibitors finasteride and/or dutasteride 4 weeks prior to randomization. * history of bilateral orchiectomy, adrenalectomy, or hypophysectomy. * history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema. * known hypersensitivity towards any component of the investigational medicinal product or casodex (bicalutamide) or their excipients. * marked baseline prolongation of qt/qtcf interval (e.g. repeated demonstration of a qtcf interval \>450 ms). * history of risk factors for torsade de pointes ventricular arrhythmias (e.g. heart failure, hypokalemia, or family history of long qt syndrome). * previous history or presence of another malignancy, other than prostate cancer or treated squamous / basal cell carcinoma of the skin, within the last five years. * clinically significant laboratory abnormalities (e.g. severe renal or hepatic impairment) which in the judgment of the investigator would affect the patient's health or the outcome of the trial. * clinically significant disorder (other than prostate cancer) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, which may affect the patient's health or the outcome of the trial as judged by the investigator. * use of natural medicines thought to have endocrine effects on prostate cancer (e.g. saw palmetto and st. john's wort) 4 weeks prior to randomization. * mental incapacity or language barrier precluding adequate understanding or co operation. * use of an investigational drug within the last 28 days preceding the screening visit or longer if considered to possibly influence the outcome of the current trial. * previously participated in any degarelix trial.
trimetazidine therapy in hypertrophic cardiomyopathy

Conditions: Hypertrophic Cardiomyopathy

Summary: hypertrophic cardiomyopathy (hcm) is a common inherited heart condition that causes breathlessness, chest pain and fatigue. there are few treatments available. the investigators have recently shown that a drug called perhexiline reduced symptoms and improved exercise capacity in patients with hcm. this change appears to be driven by alterations in myocardial energy metabolism. the aim of this trial is to test a similar drug, trimetazidine, in a group of symptomatic patients with non-obstructive hcm. hypothesis: trimetazidine will improve symptoms, peak oxygen consumption, cardiac function and arrhythmia burden in medically refractory symptomatic patients with non-obstructive hcm.

background: hypertrophic cardiomyopathy (hcm) is a common inherited disorder of heart muscle affecting 1 in 500 individuals worldwide. it is associated with arrhythmias, heart failure and sudden death in young people. in the majority of patients, hcm is caused by mutations in genes encoding cardiac contractile proteins. it has been hypothesised that excessive sarcomeric energy consumption is an important and early factor in the pathophysiology of hcm. therefore modulation of myocardial metabolism presents a novel target for improving myocardial performance and symptoms in patients with hcm. trimetazidine is an anti-anginal agent which like perhexiline reduces fatty acid oxidation and increases glucose oxidation, thus increasing the efficiency of energy production. trimetazidine has been shown to significantly improve exercise performance in patients with stable angina, ischaemic and non ischaemic cardiomyopathy, either as monotherapy or in combination with beta-blockers or calcium channel blockers, design: a single centre prospective randomised, double blind, placebo-controlled, trial of trimetazidine therapy. dosing: 20 mg trimetazidine or placebo three times daily for three months methods: the following assessments will be made at baseline and after 3 months treatment: history and physical examination, minnesota heart failure questionnaire, fasting blood tests, electrocardiogram, echocardiogram, cardiopulmonary exercise test, six minute walk test, 24 hour ecg holter monitor.

Eligibility criteria:
inclusion criteria: * non-obstructive hypertrophic cardiomyopathy (gradient \<30 mmhg at rest) * nyha (new york heart association) class ≥ 2 * peak vo2 (maximal oxygen consumption) ≤80% predicted for age and gender * heart rate \< 90/minute at rest exclusion criteria: * diabetes mellitus * abnormal renal function (gfr\<60ml/min) or hepatic impairment * female who is pregnant, lactating or planning pregnancy during the course of the study

Keywords: trimetazidine
effect of statins on the radial intima-media thickness after transradial angioplasty

Conditions: Coronary Artery Disease

Summary: the first event of the atherosclerotic plaque formation is the accumulation of the low density lipoprotein-cholesterol (ldl-cholesterol) in to the intima of the arterial wall. after accumulation of the ldl-cholesterol, the oxidation of the ldl-cholesterol particles and recruitment of monocytes to the intima and media are the next steps. the thickening of intima-media thickness (imt) is resulted from these initial events. the imt can be easily measured by high-resolution ultrasonography in various arteries including carotid, brachial and radial arteries. the increased carotid imt can be used as a non-invasive independent parameter indicating increased cardiovascular mortality. some investigators reported increased radial imt is associated with increased early failure of the radiocephalic arteriovenous fistula in the hemodialysis patients. moreover, radial imt is increased in patients underwent radial artery intervention because of denudation injury of the radial artery. recently, the use of statin can halt the progression of the carotid imt progression. however, it is unknown that the use of statin can prevent the progression of radial imt after the transradial coronary intervention. the investigators want to evaluate the effect of statins on the progression of the radial imt after the transradial intervention.


Eligibility criteria:
inclusion criteria: * patients undergoing coronary intervention via the radial artery exclusion criteria: * contraindication to statins * left ventricular ejection fraction less than 30% * recent history of hematologic disease or leukocyte count \<3000/mm3 and/or platelet \<100 000/mm3 * hepatic dysfunction with ast or alt \>3 times the upper normal reference limit * history of renal dysfunction or a serum creatinine level \>2.0 mg/dl * serious noncardiac comorbid disease with a life expectancy \<1 year * inability to follow the protocol

Keywords: coronary artery disease coronary intervention intima-media thickness
impact of vagus nerve stimulation on post-aerobic activity recovery in post sars-cov-2 patients

Conditions: Post-COVID-19 Syndrome

Summary: chronic fatigue, weakness, dyspnea, headaches, cognitive dysfunction, stress, sadness, anxiety, sleep disturbances, and orthostatic intolerance are among the symptoms of acute covid-19 in patients, and these symptoms persist for more than 12 weeks after recovery. extended covid-19 syndrome, also known as post-covid-19 syndrome, is described as

therapeutic exercises are an evidence-based method for the maintenance of musculoskeletal, cardiovascular and neurological well-being and the prevention and treatment of chronic diseases. the effects of therapeutic exercises on the human body varied according to the frequency, intensity, duration and type of exercise. increasing physiological and psychological recovery after exercise can lead to results such as better performance and reducing the risk of injury. therefore, various methods are used to facilitate post-exercise recovery. the best-known and most widely used post-exercise recovery method is active cooling, also known as active rest or cool-down. active cooling; it is defined as any activity that includes voluntary, low/moderate intensity exercise or movement performed within one hour of exercise. passive rest, on the other hand, is defined as no or minimal voluntary/intentional exercise movement.

Eligibility criteria:
inclusion criteria: * covid * be between 18-45 years old * having pulmonary involvement in the covid process exclusion criteria: * being a professional in any sport * having a cardiopulmonary, orthopedic, neurological and metabolic disease
a single-dose,comparativebioavailability study oftwo formulations oferlotinib150mgtabletsunderfastingconditions

Conditions: Lung Cancer

Summary: theobjectiveofthisstudyistoevaluatethecomparativebioavailabilitybetween: * erlotinibhcl150mgtablets(novopharm limited,canada)and * tarceva® 150mgtablets(hoffmann-larochelimited,canada) afterasingle-doseinhealthysubjectsunderfastingconditions.

this is a blinded,single-dose,randomized,two-period,two-sequence,two-treatment,cross over study, designed to evaluate the comparative bioavailability of two formulations of erlotinib hcl 150mg tablets administered to healthy male and female subjects under fasting conditions. • subjectswererandomlyassignedtooneofthetwodosingsequencesaborba underfasting conditions.

Eligibility criteria:
inclusion criteria: * healthy, non-smoking, post-menopausal and/or surgically sterile female subjects * healthy,non-smoking male subjects. allsubjects willbe from 18 to 55 years ofage. exclusion criteria: * known history or presence of any clinically significant medicalcondition. * known or suspected carcinoma. * presence ofclinically significant gastrointestinal disease or history of malabsorption within the last year. * presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption. * use of tobacco or nicotine-containing products within 6 months priorto drug administration.
pemetrexed plus gemcitabine in metastatic breast cancer patients after receiving taxane therapy

Conditions: Breast Cancer; Breast Neoplasms

Summary: the purpose of the study is to determine if the two drugs can help patients feel better while causing the tumor to become smaller or disappear; evaluate the safety of giving both pemetrexed and gemcitabine in patients with advanced breast cancer.


Eligibility criteria:
inclusion criteria: * must have received prior chemotherapy with taxol (paclitaxel) or taxotere (docetaxel). * less than 3 different chemotherapy treatments for metastatic disease. * prior treatment with hormonal and/or radiation therapy. * must have disease that can be measured. * must be able to take care of self needs for example personal hygiene exclusion criteria: * must not be pregnant or breast-feeding. * cancer that has spread to the brain. * treatment with gemcitabine or pemetrexed * unable to take folic acid or vitamin b12 * treatment for another cancer within the last 5 years

Keywords: cancer of breast cancer of the breast
a study to evaluate the efficacy and safety of da-5204

Conditions: Acute Gastritis; Chronic Gastritis

Summary: this is a multicenter, active-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy and safety of da-5204 and to demonstrate the non-inferiority of da-5204 compared with stillen® tab. in patients with acute or chronic gastritis.


Eligibility criteria:
inclusion criteria: * age is over 20 years old, under 75 years old, men or women * patients diagnosed with acute or chronic gastritis by gastroscopy * patients with one or more erosions found by gastroscopy * signed the informed consent forms exclusion criteria: * patients who is impossible to receive gastroscopy * patients with peptic ulcer and gastroesophageal reflux disease * patients administered with prokinetics, h2 receptor antagonists, proton pump inhibitors, anticholinergic drugs or non-steroid anti-inflammatory drugs prior to study in 2 weeks * patients with surgery related to gastroesophageal * patients with zollinger-ellison syndrome * patients with any kind of malignant tumor * patients administered with anti-thrombotic drugs * patients with significant cardiovascular, pulmonary, heptic, renal, hemopoietic or endocrine system primary disease * patients with neuropsychiatric disorder, alcoholism, or drug abuse * patients taking other investigational drugs or participating in other clinical studies in 4 weeks. * women either pregnant or breast feeding
search a correlation between lp(a) rate and tfpi activity in obese patients with chest pain like angina

Conditions: Atherosclerosis

Summary: atherosclerotic cardiovascular disease is a leading cause of mortality in our countries. clinically, symptoms could be chest pain suggesting stable angina. atherosclerosis is influenced by cardiovascular risk factors which obesity (body mass index\>30). obesity is associated with an increase risk of cardiovascular complications. lipoprotein(a) is regarded as an independent risk factor for premature cardiovascular disease. lp(a) is composed of low-density lipoprotein - like particle bound to glycoprotein molecule: apolipoprotein(a). plasma levels are determinated to more than 90% by genetic factors (no significant influence of statin, weight, lifestyle factor: diet, exercise). two study with few patients have found that aspirin lowers serum lp(a) levels. elevated lp(a) is a risk factor for recurrent coronary events in obese patient. atherosclerosis is associated with imbalance of coagulation. tfpi (tissue factor pathway inhibitor) is the earliest inhibitor of the blood coagulation process, natural direct inhibitor of tissue factor. in-vitro, tfpi activity is inhibited by high lp(a) . the aim of this study is to research reverse association between lp(a) and tfpi activity in obese patient with chest pain like stable angina suggesting atherosclerotic heart disease and effect of aspirin.


Eligibility criteria:
inclusion criteria: * major * men * obese bmi\>30 * no aspirin treatment before inclusion * coronary exploration: coronary angiography or tomography coronary angiography * chest pain like stable angina exclusion criteria: * women * severe hepatic insufficiency * inflammatory disease * neoplasia * protein s deficiency * aspirin treatment 10 days before inclusion * oral anticoagulant treatment at inclusion * heparin or low molecular weight heparin treatment at inclusion

Keywords: obesity men tfpi lipoprotein(a) lp(a) tissue factor pathway inhibitor aspirin